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Software as a Medical Device (SaMD)

Russia's framework for SaMD​

Roszdravnadzor published methodological guidelines in 2018 establishing when standalone software qualifies as a medical device and how it should be registered. Russia was one of the earlier regulators to issue specific SaMD guidance.

The guidelines establish:

  • Criteria for classifying software as a medical device based on its intended use
  • Principles for classification — which risk class (I–III) applies to different software types
  • Criteria for non-compliance that may be identified during the FGBU expert review
  • Assessment algorithms for technical documentation review
  • A list of applicable national standards for software evaluation

When software is a medical device​

Software is treated as a medical device in Russia when the manufacturer declares an intended use that falls within the scope of Article 38 of Federal Law 323-FZ — for example:

  • Software that analyses medical images to assist in diagnosis
  • Clinical decision support software that makes patient-specific treatment recommendations
  • Software monitoring vital signs and generating alerts
  • Telemedicine platforms providing clinical diagnosis or treatment recommendations for individual patients

General-purpose analytics tools, electronic health records without decision-support functions, and administrative software are generally not considered medical devices.

Classification of SaMD​

Software classified as a medical device receives a risk class (I, IIa, IIb, or III) based on the same criteria applied to hardware devices. The potential harm from software failure or error is the key criterion. AI/ML software used in high-stakes clinical decisions (oncology diagnosis, cardiac rhythm analysis) will typically be Class IIb or III.

OKPD-2 codes for software​

The official OKPD-2 classification list was updated to include codes specifically for medical software. The correct OKPD-2 code must be assigned when preparing the registration dossier.

Technical documentation for SaMD​

The technical dossier for a software medical device must include:

  • Software description and architecture
  • Intended purpose and intended user
  • Version control and lifecycle management documentation
  • Cybersecurity risk assessment
  • Clinical and analytical validation data
  • Instructions for use in Russian

AI and machine learning​

AI/ML-based medical devices follow the same SaMD framework. Russia has engaged with IMDRF work on AI in healthcare (Russia chaired IMDRF during the 2019 meeting where AI was a key topic). There is no separate AI-specific regulation, but the FGBU review process for AI devices examines validation methodology carefully.

Official source

Roszdravnadzor methodological guidelines on medical software (2018): roszdravnadzor.gov.ru